In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection.

"You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive.

The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law.

The report, partially redacted, was not accompanied by a warning letter.

A former FDA official who asked not to be identified, however, said the deficiencies - 79 in all, from incorrectly labeled products to failed sterility tests - are so serious that Celltex risks being shut down if it does not remedy the problems quickly.

Adult stem cells are cells in the body that multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have shown promise for tissue repair in many other diseases in the last decade, although most scientists in the field consider them not ready for mainstream use.

Rules take effect July 8

Celltex has been in the public eye since it was revealed that Perry's Houston doctor treated him with his own stem cells during back surgery last July and in follow-up appointments. His stem cells were stored and grown at Celltex.

Perry subsequently called for Texas to become the nation's leader of adult stem cell medicine, which he touts as an ethical alternative to embryonic stem cells. Perry worked with his Houston doctor and a state representative to write legislation intended to commercialize the therapy in Texas.

In April, the Texas Medical Board approved rules regulating the therapy, which isn't approved by the FDA. The rules allow doctors to use stem cells as long as they get the approval of a review board that evaluates clinical research for safety. The board members were all appointed by Perry.

Those rules will be published in the Texas Register Friday and begin taking effect July 8.

A spokeswoman for Perry called the report a matter "between the company and FDA." In a statement, she said Perry's surgery was "a success" and "he remains committed to supporting adult stem cell research and the safe implementation of its therapies in Texas, which hold the promise of improving and saving lives."

Findings downplayed

Celltex CEO David Eller downplayed the findings, saying the company invited the inspection. "As you can see from the agency's constructive observations, we shared proprietary information on all aspects of our laboratory operations," Eller wrote in a statement. "The FDA is already aware we have resolved many of its observations and we are working to address the remainder."

The statement said Celltex has continued to provide "stem cell banking and expansion services" without interruption after the FDA visit.

The highly technical report lists Celltex as a manufacturer of biological drugs, a category of living cells that includes vaccines, gene therapy and blood products. It does not address whether Celltex was engaging in more than the minimal manipulation the agency allows without its oversight.

Instead, the FDA focused on manufacturing deficiencies. The report says Celltex failed to validate processes necessary to prevent contamination; to distinguish between components being quarantined, approved or rejected; to routinely calibrate and check equipment; to record the temperature or humidity of processing rooms; and to review quality control processes.

'Sloppy' procedures

Leigh Turner, the Minnesota bioethicist who filed the FDA complaint, said the agency's visit showed why it was important to inspect the site. He said he was surprised at the number of "sloppy, unprofessional" procedures the FDA found.

Paul Knoepfler, a University of California Davis School of Medicine professor of biology whose laboratory conducts research on adult, embryonic, and cancer stem cells, said the report is a blow to the entire adult stem cell industry because Perry's procedure "thrust Celltex into the limelight and made it viewed as leading the way."

Turner, Knoepfler and the former FDA official all expressed skepticism that the inspection was a result of an invitation by the company.

"The deficiencies identified reflect significant problems, serious issues," said Knoepfler, who has written frequently about Celltex in his blog on stem cells. "If I were a patient, they would scare me off big time."